BEUDAMED
    FDA Adverse Event Other Summary report: N

    MR HISPEED SYSTEM

    MDR report key: 163213 · Received April 16, 1998

    Report

    Report Number
    2183553-1998-00002
    Event Type
    Other
    Date Received
    April 16, 1998
    Date of Event
    May 14, 1997
    Report Date
    April 16, 1998
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    LNH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE AS A RESULT OF A LAWSUIT THAT A PT EXPERIENCED TINNITUS FOLLOWING AN MR SCAN. THE MR SYSTEM OPERATOR'S MANUAL WARNS THE OPERATOR TO PROVIDE THE PT WITH EAR/HEARING PROTECTION DURING A SCAN. THE PT RECEIVED EAR/HEARING PROTECTION FROM THE TECHNOLOGIST AND THESE WERE INSERTED BY THE TECHNOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR HISPEED SYSTEM MAGNETIC RESONANCE LNH GENERAL ELECTRIC MEDICAL SYSTEMS 46-281380G5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other